British journal of clinical pharmacology最新文献

{"title":"Implementability of opioid deprescribing interventions at transitions of care: A scoping review","authors":"Jeffery Wang,&nbsp;Carl R. Schneider,&nbsp;Aili V. Langford,&nbsp;Mouna Sawan,&nbsp;Chung-Wei Christine Lin,&nbsp;Antonius Nugraha Widhi Pratama,&nbsp;Danijela Gnjidic","doi":"10.1111/bcp.16369","DOIUrl":"10.1111/bcp.16369","url":null,"abstract":"<p>Continuation of opioids at transitions of care increases the risk of long-term opioid use and related harm. To our knowledge, no study has examined the implementability of opioid deprescribing interventions at transitions of care. Our scoping review aimed to identify the type of opioid deprescribing interventions employed at transitions of care and assess the implementability of tested interventions. Nine electronic databases were searched on 15 May 2023 for English-language studies of adults transitioning between care settings, where opioid deprescribing interventions targeting patients, clinicians or health systems were implemented. Implementability was assessed using the Cochrane Intervention Complexity Assessment Tool for Systematic Reviews to determine intervention complexity, and mapped to the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to understand the process evaluation. A total of 79 studies were identified, with 94.0% (<i>n =</i> 74) examining hospital-to-home transitions. Mixed interventions (combination of pharmacological and nonpharmacological) were tested in 49.0% (<i>n =</i> 39) of studies. Pharmacological interventions were identified in 31.0% (<i>n =</i> 24) of studies, and the remaining 20.0% (<i>n =</i> 16) applied nonpharmacological interventions. Mixed interventions comprising multiple components were the most complex and resulted in reduced opioid use across transitions of care in 28.0% (<i>n =</i> 22) of studies. Few studies reported on RE-AIM dimensions including implementation (5.0% of studies), reach (4.0%), adoption (4.0%) and maintenance (0%). Most opioid deprescribing interventions targeted hospital to home care transition with mixed results in opioid deprescribing. Further research should consider the implementability of interventions during transitions of care to elucidate the impact of opioid deprescribing interventions across care settings.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":"91 3","pages":"698-728"},"PeriodicalIF":3.1,"publicationDate":"2024-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142876166","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Strategies employed and experiences associated with the implementation of pharmaceutical services and interventions in geriatric wards: A scoping review","authors":"Alan Maicon de Oliveira,&nbsp;João Paulo Vilela Rodrigues,&nbsp;Isabella do Vale de Souza,&nbsp;Thalita Zago Oliveira,&nbsp;Márcia dos Santos,&nbsp;Fabiana Rossi Varallo,&nbsp;Leonardo Régis Leira Pereira","doi":"10.1111/bcp.16373","DOIUrl":"10.1111/bcp.16373","url":null,"abstract":"<p>Evidence indicates a lack of clarity regarding the contributions of interventions aimed at optimizing pharmacotherapy, primarily guided by pharmaceutical care, for clinically significant improvements in older individuals. Thus, there is a need to deepen the understanding of this scenario and the factors involved. Therefore, this study aims to map and summarize scientific evidence regarding experiences and strategies employed in providing pharmaceutical services and interventions in geriatric wards. A scoping review was conducted based on 3 electronic databases (PubMed, EMBASE and Web of Science). Studies meeting the inclusion criteria, published up to September 2024, and in English, Spanish or Portuguese were selected. Experimental and observational studies were eligible for inclusion. Screening, eligibility, extraction and assessment of the studies were carried out by 2 independent researchers. The exploration of bibliographic databases yielded 3,976 references, and 40 studies were deemed suitable for inclusion. Predominantly conducted in countries with high human development, these studies categorized services and interventions as: (i) medication review; (ii) medication reconciliation; and (iii) pharmaceutical counselling. Highlighted tools included STOPP and START criteria, Beers criteria, and the Medication Appropriateness Index, facilitating identification of issues such as potentially inappropriate medications (27.6–90.8% of older individuals using at least 1 potentially inappropriate medication), drug-related problems (34.5–98.2% of patients with at least 1 drug-related problem) and adverse drug events (58–88.4% of patients with at least 1 adverse drug event). The acceptance rate of interventions exhibited considerable variation (13–95.3%). Only 10 studies evaluated clinical outcomes in patients. Barriers included the need for additional training for pharmacists in geriatrics, significant time investment, lack of continuity in assessments and a lack of recognition of interventions by other members of the multiprofessional team. There is a clear trend towards improving medication prescription adequacy and contributing to the quality of pharmacotherapy through pharmaceutical services and interventions in geriatric wards. However, several gaps still need to be addressed, and this review emphasizes identifying obstacles to be overcome, providing guidance for future investigations.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":"91 3","pages":"729-739"},"PeriodicalIF":3.1,"publicationDate":"2024-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142876170","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A systematic review and meta-analysis of interventions to delabel low-risk penicillin allergies with consideration for sex and gender","authors":"Mira Maximos,&nbsp;Ryan Pelletier,&nbsp;Sameer Elsayed,&nbsp;Colleen J. Maxwell,&nbsp;Sherilyn K. D. Houle,&nbsp;Brie McConnell,&nbsp;John-Michael Gamble","doi":"10.1111/bcp.16366","DOIUrl":"10.1111/bcp.16366","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>Sex and gender may influence penicillin allergy label (PAL) prevalence and outcomes. This review evaluates the effectiveness and safety of direct delabelling (DD) and oral challenge (OC) for low-risk patients and examines sex and gender differences in reporting and outcomes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We searched PubMed, Database of Abstracts of Reviews and Effects, ClinicalTrials.gov, Cochrane Database of Systematic Reviews, International Pharmaceutical Abstracts, medRxiv, Ovid MEDLINE, and Ovid EMBASE until February 2024 for studies including DD or OC compared to no intervention, skin testing or other methods. Two reviewers assessed quality. Meta-analyses were conducted, and subgroup analyses were carried out if <i>I</i>² &gt;   75%. Descriptive data was analysed using NVivo 14 and reported narratively.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>From 1046 screened studies, 28 met inclusion criteria (two RCTs, 26 quasi-experimental studies). Sex at baseline was reported in 86% of studies, with 61% females: 18% disaggregated outcomes by sex with a female mean delabelling rate of 66%. Gender variables were not reported. OC was not found to be more or less as effective comparaed to skin testing in RCTs (risk ratio [RR] 1.04; 95% confidence interval [CI] 0.95, 1.13, <i>I</i>² = 74%). DD interventions had a 27% delabelling rate (95% CI 10%, 50%, <i>I</i>² = 96%), with nursing staff achieving 29% (95% CI 15%, 47%, <i>I</i>² = 63%) and allergists/immunologists 6% (95% CI 0.00, 0.00, <i>I</i>² = 20%). Quasi-experimental studies reported 90% delabelling for OC, with 59% by allergists/immunologists and 90% by pharmacists. Adverse events averaged 4% and were non-severe.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>DD and OC are effective for delabelling low-risk penicillin allergies. Comprehensive data is lacking on sex and gender differences, indicating a need for further research.</p>\u0000 </section>\u0000 </div>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":"91 3","pages":"684-697"},"PeriodicalIF":3.1,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/bcp.16366","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142863497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cytochrome P450 phenotyping using the Geneva cocktail improves metabolic capacity prediction in a hospitalized patient population.","authors":"Yvonne S Gloor, Médéric Mouterde, Jean Terrier, Camille Lenoir, Pauline Gosselin, Victoria Rollason, Jean-Luc Reny, Sotiria Boukouvala, Said Al-Yahyaee, Getnet Yimer, Viktor Černý, Estella S Poloni, Caroline F Samer, Youssef Daali","doi":"10.1111/bcp.16368","DOIUrl":"https://doi.org/10.1111/bcp.16368","url":null,"abstract":"<p><strong>Aims: </strong>Liver cytochromes (CYPs) play an important role in drug metabolism but display a large interindividual variability resulting both from genetic and environmental factors. Most drug dose adjustment guidelines are based on genetics performed in healthy volunteers. However, hospitalized patients are not only more likely to be the target of new prescriptions and drug treatment modifications than healthy volunteers, but will also be more subject to polypharmacy, drug-drug interactions, or to suffer from disease or inflammation affecting CYP activities.</p><p><strong>Methods: </strong>We compared predicted phenotype based on genetic data and measured phenotype using the Geneva cocktail to determine the extent of drug metabolizing enzyme variability in a large population of hospitalized patients (>500) and healthy young volunteers (>300). We aimed to assess the correlation between predicted and measured phenotype in the two populations.</p><p><strong>Results: </strong>We found that, even in cases where the genetically predicted metabolizer group correlates well with measured CYP activity at group level, this prediction lacks accuracy for the determination of individual metabolizer capacities. Drugs can have a profound impact on CYP activity, but even after combining genetic and drug treatment information, the activity of a significant proportion of extreme metabolizers could not be explained.</p><p><strong>Conclusions: </strong>Our results support the use of measured metabolic ratios in addition to genotyping for accurate determination of individual metabolic capacities to guide personalized drug prescription.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142863498","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost-effectiveness of first-line systemic therapies for unresectable hepatocellular carcinoma.","authors":"Dai Lian, Yuling Gan, Dunming Xiao, Dennis Xuan, Shimeng Liu, Yan Wei","doi":"10.1111/bcp.16367","DOIUrl":"https://doi.org/10.1111/bcp.16367","url":null,"abstract":"<p><strong>Aims: </strong>To examine the cost-effectiveness of first-line systemic therapies recommended by the National Comprehensive Cancer Network guidelines for Unresectable Hepatocellular Carcinoma (uHCC) from the US social and payer's perspective.</p><p><strong>Methods: </strong>A cost-effectiveness analysis was conducted using a three-state partitioned survival model to assess the cost-effectiveness of atezolizumab plus bevacizumab, tremelimumab plus durvalumab, durvalumab, lenvatinib and sorafenib as first-line treatments for uHCC. Clinical efficacy was derived from a published network meta-analysis. Cost and utility inputs were collected from literature. Main outcomes measured were quality-adjusted life year (QALY), and incremental cost-effectiveness ratio (ICER). Univariate and probabilistic sensitivity analyses, as well as scenario analyses were performed.</p><p><strong>Results: </strong>Over a 10-year time horizon, atezolizumab plus bevacizumab yielded the highest QALYs. Compared to sorafenib, atezolizumab plus bevacizumab, tremelimumab plus durvalumab and lenvatinib had ICERs of $196 704/QALY, $800 755/QALY and $2 032 756/QALY, respectively. Sorafenib was dominated by durvalumab due to lower QALYs and higher costs. At a willingness-to-pay threshold of $150 000/QALY, probabilistic sensitivity analysis revealed that durvalumab had a 99.96% probability of providing the highest net monetary benefit.</p><p><strong>Conclusions: </strong>At a willingness-to-pay threshold of $150 000/QALY, durvalumab is likely the most cost-effective first-line systemic therapy for uHCC compared to sorafenib. Although atezolizumab plus bevacizumab yielded the highest QALYs, their ICERs exceeded the commonly accepted cost-effectiveness threshold ($150 000$ per QALY gained). These findings can inform clinical decision-making, resource allocation and future research priorities in managing uHCC.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142852927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the effect of making the indication field compulsory in electronic prescriptions: A pre-post study in a hospital prescribing system.","authors":"Lorna Pairman, Paul Chin, Matthew Doogue","doi":"10.1111/bcp.16370","DOIUrl":"https://doi.org/10.1111/bcp.16370","url":null,"abstract":"<p><strong>Aims: </strong>Recording the indication for a medicine in the prescription supports communication. In May 2023, our district hospitals made the free-text indication field in prescriptions compulsory for all medicines in the inpatient prescribing system. This study aimed to evaluate the effect of introducing a compulsory indication field in an inpatient prescribing system.</p><p><strong>Methods: </strong>Text in the indication field was manually classified as an indication, 'other text', 'rubbish text', 'to be determined' and 'blank'. Prescribing data were extracted from the district data warehouse. The change in proportion of prescriptions with an indication was compared for 8 weeks after introduction of a compulsory indication field to an equivalent 8 weeks in 2022. Secondary outcomes included medication cessation and indication recording before discharge.</p><p><strong>Results: </strong>We analysed 81 634 prescriptions before and 82 726 after indications were made compulsory. The proportion of prescriptions with an indication increased from 29.2% to 75.6%. 'Rubbish text' increased from 0% to 2.3%, 'other text' from 2.5% to 14.7%, and 'to be determined' from 0.0% to 6.6%. Of 5557 prescriptions with 'to be determined' initially, 18.1% were ceased and 2.7% had an indication before discharge.</p><p><strong>Conclusions: </strong>After making the prescription indication field compulsory, the proportion of medicines with an indication increased from 29% to 76%, with only a small increase in 'rubbish text'. Following the system change, the quality of information recording improved but there was no change in medicine use. Compulsory fields should be combined with improvements in other components of care to improve medicine use.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142852943","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Potential of melatonin as a treatment option for long COVID: A call for research","authors":"Urmisha U. Kakad,&nbsp;Priyanka S. Khopkar-Kale,&nbsp;Srikanth P. Tripathy,&nbsp;Jitendra S. Bhawalkar","doi":"10.1111/bcp.16375","DOIUrl":"10.1111/bcp.16375","url":null,"abstract":"&lt;p&gt;The 21st century's most significant public health crisis is the COVID-19 pandemic. Patients and society face prolonged consequences related to COVID-19, which is generally known as long COVID. New treatments are still under development.&lt;span&gt;&lt;sup&gt;1&lt;/sup&gt;&lt;/span&gt; While the development of drugs can take over a decade, we should explore currently approved medications for patients in the meantime.&lt;/p&gt;&lt;p&gt;Melatonin is well known for governing sleep–wake cycles and has more than 50 years of safe use. Initially, it was described as a hormone product of the pineal gland. However, it is now realized to be synthesized and secreted from tissues that include the retina, bone marrow, gastrointestinal tract and the placenta.&lt;span&gt;&lt;sup&gt;2&lt;/sup&gt;&lt;/span&gt;&lt;/p&gt;&lt;p&gt;Long COVID shows a variety of symptoms, among which neuropsychiatric symptoms like brain fog, memory impairment, anxiety and insomnia are prevalent, for which neuroinflammation, oxidative stress and mitochondrial dysfunction are the fundamental mechanisms.&lt;span&gt;&lt;sup&gt;3&lt;/sup&gt;&lt;/span&gt;&lt;/p&gt;&lt;p&gt;Inflammation in long COVID is often associated with a cytokine storm that disrupts the blood–brain barrier. The latter allows proinflammatory cytokines, such as IL-6, to activate microglia in the brain, shifting towards a proinflammatory phenotype and exacerbating neuroinflammation. Melatonin may prevent it by decreasing the release of proinflammatory cytokines, including TNF-α, IL-1β and IL-6 while stimulating sirtuin-1-mediated production of the anti-inflammatory cytokine IL-10. Furthermore, by increasing the expression of nuclear factor erythroid 2-related factor 2 (NRF2) activity, melatonin helps restore the balance between reactive oxygen species (ROS) and antioxidants to manage oxidative stress. This modulation of inflammatory pathways could potentially reduce neuroinflammation and thus may reduce symptoms in the long COVID patients suffering from cognitive and mood disturbances. Mitochondrial dysfunction, often seen in chronic inflammatory states, can be relieved by melatonin by improving mitochondrial function, reducing oxidative damage and restoring energy production, which may help alleviate symptoms like fatigue and cognitive impairment.&lt;span&gt;&lt;sup&gt;2, 4&lt;/sup&gt;&lt;/span&gt;&lt;/p&gt;&lt;p&gt;Some studies have assessed the impact of melatonin in patients with acute infection of COVID-19. A randomized control trial (RCT) demonstrated that 5mg oral melatonin improved the CRP and ESR.&lt;span&gt;&lt;sup&gt;5&lt;/sup&gt;&lt;/span&gt; Similarly, a randomized double-masked clinical trial (3mg melatonin)&lt;span&gt;&lt;sup&gt;6&lt;/sup&gt;&lt;/span&gt; and pilot study (6mg melatonin)&lt;span&gt;&lt;sup&gt;7&lt;/sup&gt;&lt;/span&gt; found that melatonin significantly improved CRP levels.&lt;/p&gt;&lt;p&gt;Although many reports indicate melatonin's positive impact on COVID-19 patients, it is critical to conduct clinical trials explicitly focusing on the effect in long COVID. Some studies are already being conducted to determine its role in COVID-19. However, the optimal dosing and efficiency of melatonin for managing neuropsych","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":"91 2","pages":"493-494"},"PeriodicalIF":3.1,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/bcp.16375","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142833824","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Establishing reference ranges for circulating biomarkers of drug-induced liver injury in healthy human volunteers.","authors":"Andrea L Jorgensen, Samantha Korver, Amy Schofield, Lawrence Howell, Joanna I Clarke, Lauren E Walker, Nathalie Brillant, Chris E P Goldring, Munir Pirmohamed","doi":"10.1111/bcp.16371","DOIUrl":"https://doi.org/10.1111/bcp.16371","url":null,"abstract":"<p><strong>Aims: </strong>The potential of mechanistic biomarkers to improve prediction of drug-induced liver injury (DILI) and hepatic regeneration is widely acknowledged. We sought to determine reference intervals for new biomarkers of DILI and regeneration, as well as to characterize their natural variability and impact of diurnal variation.</p><p><strong>Methods: </strong>Serum samples from 227 healthy volunteers were recruited as part of a cross-sectional study; of these, 25 subjects had weekly serial sampling over 3 weeks, while 23 had intensive blood sampling over a 24h period. Alanine aminotransferase (ALT), MicroRNA-122 (miR-122), High Mobility Group Box-1 (HMGB1), total Keratin-18 (K18), caspase-cleaved Keratin-18 (ccK18), Glutamate Dehydrogenase (GLDH) and Macrophage Colony-Stimulating Factor-1 (CSF-1) were assayed.</p><p><strong>Results: </strong>Reference intervals were established for each biomarker based on the 97.5% quantile (90% CI) following the assessment of fixed effects in univariate and multivariable models. Intra-individual variability was found to be non-significant, and there was no significant impact of diurnal variation.</p><p><strong>Conclusion: </strong>Reference intervals for novel DILI biomarkers have been described. An upper limit of a reference range might represent the most appropriate mechanism to utilize these data. These data can now be used to interpret data from exploratory clinical DILI studies and to assist their further qualification as required by regulatory authorities.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827494","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"β-Blockers and risk of neuropsychiatric disorders: A systematic review and meta-analysis","authors":"Lujain Ez Eddin,&nbsp;Rebecca Preyra,&nbsp;Fatemeh Ahmadi,&nbsp;Atefeh Jafari,&nbsp;Mohammad Ali Omrani,&nbsp;Flory T. Muanda","doi":"10.1111/bcp.16361","DOIUrl":"10.1111/bcp.16361","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>This systematic review and meta-analysis aimed to evaluate the association between β-blocker use and neuropsychiatric adverse events, specifically focusing on short-term outcomes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A comprehensive literature search identified studies reporting neuropsychiatric outcomes in patients using β-blockers, including randomized controlled trials and observational studies. Relative risks (RR) and 95% confidence intervals (CIs) were calculated for outcomes such as dizziness, insomnia, nightmares, drowsiness and delirium.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Our analysis revealed that β-blocker use was significantly associated with an increased risk of dizziness (RR 1.72, 95% CI [1.39–2.14]; <i>I</i>² = 1%, 14 studies) compared to placebo. Lipophilic β-blockers, especially propranolol, showed an even greater risk of dizziness (RR 3.13, 95% CI [1.44–6.84]; <i>I</i>² = 0%, three studies). Propranolol was also associated with increased insomnia risk compared to placebo (RR 1.13, 95% CI [1.00–1.28]; <i>I</i>² = 0%, five studies). Our data did not show statistically significant increases in the reports of nightmares and somnolence. Other adverse effects, including drowsiness, sleep disturbances, hallucinations and delirium, were noted.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Our findings suggest a significant association between β-blocker use and an increased risk of neuropsychiatric adverse events, particularly insomnia and dizziness with higher risks associated with lipophilic β-blocker use. Given the ambiguity surrounding dizziness and its classification as a neuropsychiatric effect, our findings are exploratory, and we cannot exclude a potential cardiovascular origin for dizziness. Most studies (75%) were published before the CONSORT statement in 1996, indicating potential reporting limitations and a lack of recent research. Additionally, 60% of studies had a high risk of bias, underscoring the need for more rigorous and contemporary investigations into the neuropsychiatric implications of β-blocker use.</p>\u0000 </section>\u0000 </div>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":"91 2","pages":"325-337"},"PeriodicalIF":3.1,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11773113/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142806177","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The safety profile of usage of glucagon-like peptide-1 receptor agonists in pregnancy: A pharmacovigilance analysis based on the Food and Drug Administration Adverse Event Reporting System.","authors":"Jianxing Zhou, Zipeng Wei, Weipeng Lai, Maobai Liu, Xuemei Wu","doi":"10.1111/bcp.16354","DOIUrl":"https://doi.org/10.1111/bcp.16354","url":null,"abstract":"<p><strong>Aims: </strong>The use of (GLP-1 RAs) among pregnant women is escalating, yet safety data remain insufficient. This study aims to comprehensively assess adverse drug reactions (ADRs) associated with GLP-1 RAs in pregnant women using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.</p><p><strong>Methods: </strong>FAERS data from 2004 to 2023 were analysed, focusing on pregnant women aged 15-55 years exposed to GLP-1 RAs. Descriptive analysis covered patient demographics, clinical aspects and annual trends. Disproportionality analysis used reporting odds ratio and Bayesian confidence propagation neural network to detect ADR signals.</p><p><strong>Results: </strong>Among 354 cases with 1671 ADR reports, an exponential rise in reported cases since 2012 was observed. The median age of the affected women was 36 years, with 50.56% classified as advanced age pregnant. The disproportionality analysis revealed significant ADR signals in the reproductive (n = 199) and gastrointestinal systems (n = 155), with spontaneous abortion and pre-eclampsia being the most concerning. Additionally, while no significant dose-related differences were found, the age subgroup analysis indicated heightened risk across most age groups, except for those aged 20-24 years, highlighting the need for careful monitoring of GLP-1 RAs used during pregnancy.</p><p><strong>Conclusion: </strong>This study highlights increasing GLP-1 RA use in pregnant women and identifies potential pregnant ADRs. GLP-1 RAs are not recommended for use during pregnancy. In cases of unintentional exposure, close monitoring is advised to ensure maternal and foetal safety. These findings provide valuable insights for clinicians making informed decisions and regulators considering using GLP-1 RA in pregnancy.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142806160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}